Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Xuzhou Medical University

Status: Completed

Conditions: Type 2 Diabetic Nephropathy

Treatments: Drug: Dulaglutide Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06182891

XYFY2021-KL236-02

Details and patient eligibility

About

The purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2 Diabetic Nephropathy.

Full description

Related studies have found that Glucagon-like peptide-1 (GLP-1) receptors are localized on a variety of tissues and cell types in addition to pancreatic β-cells, and GLP-1 and GLP-1 receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic potential physiological, pathophysiological as well as pharmacological implications. Multiple clinical trials suggest that GLP-1 receptor agonists can exert renoprotective effects and persuasively inhibit the progression of kidney disease in type 2 diabetic patients. The beneficial effects of GLP-1 receptor agonists on Type 2 Diabetic Nephropathy, independent of their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory and natriuresis properties. However, it is not clear whether the above-mentioned properties are involved in the EMT process of renal tubular epithelial cells.

All participants meeting all eligibility criteria received routine medical consultations. During routine medical visits, patients were randomized into two groups (1.07:1) to receive a total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic agents not including GLP-1 receptor agonists (intervention group), and other hypoglycemic agents not including GLP-1 receptor agonists (control group). A random number method was applied for grouping in this study. Dulaglutide and other hypoglycemic agents were administered according to the drug package insert. Of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adults aged 18 and above
• No minors involved in the study
• Diabetic Nephropathy defined as a urinary albumin-to-creatinine ratio ≥30 mg/g at least twice in three measurements within a period of 3-6 months

Exclusion criteria

• Patients with other types of kidney disease
• Urinary tract infection
• Type 1 diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Dulaglutide

Experimental group

Description:

Dulaglutide was injected subcutaneously at standard dose and frequency for consecutive 12 months.

Treatment:

Drug: Dulaglutide Injection

other hypoglycemic agents not including GLP-1 receptor agonists

Active Comparator group

Description:

Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.

Treatment:

Drug: Dulaglutide Injection